The office of Controller General of Patents & Designs has intimated Union Commerce Ministry the need to notify the lapse of validity of the exclusive manufacturing rights (EMR) given to Novartis on its anti-cancer drug Glivec (imatinib mesylate). The request has come in the wake of the Patents office's rejection of Novartis patent application for Glivec on January 25, 2006. The notification is a technical obligation before the EMR can be termed invalid, it is learnt.
As per the rules, an EMR will be valid for a period of five years or till the date of grant of the patent or date of rejection of the application for the grant of patent, whichever is earlier.
The recall of EMR on Glivec is eagerly awaited by the Indian pharma majors who had withdrawn their generic brands of imatinib mesylate soon after the grant of EMR. Companies like Cipla, Ranbaxy and Sun Pharma were all having generic versions of imatinib mesylate in the market during the pre-EMR days. Natco was the only company that continued to market its brand 'Veenat' on the basis of a court intervention in favour of that company.
The lapse of EMR took place after the patent office disagreed with most of the contentions of the applicant on crucial matters like prior publication, obviousness and priority. Disposing off the case, the patent office felt that the applicant (Novartis) failed to prove enhanced efficacy of the beta-isomer over the known substance and concluded that the product was not patentable.